GW tests Pfizer’s new vaccine for C. diff
If you’ve ever been hospitalized, you may have heard of C. diff. Short for Clostridium difficile, the highly contagious drug-resistant bacteria infects half a million people every year, killing almost 30,000 Americans annually.
Scientists first identified C. diff in 1935, but in recent decades, due to antibiotic overuse, it has reached epidemic levels, particularly in hospitals. It causes severe diarrhea, fever, nausea and bloody stools. Most (80%) of the people who die from these infections are over 65.
Now Pfizer is testing a vaccine that could prevent C. diff infections.
If the vaccine works, “it would enormously cut down on illness and deaths — and costs to the healthcare system overall, by billions of dollars,” said Dr. David Diemert, director of George Washington University’s Vaccine Research Unit.
George Washington University is one of the 83 locations of the research study, known as the Beethoven study. Sponsored by Pfizer, the Phase III clinical trial will evaluate the safety and effectiveness of an investigational vaccine, which has not yet been approved by the FDA.
According to the CDC, C. diff spreads when people touch contaminated surfaces or don’t wash their hands. Hand sanitizer doesn’t kill C. diff.
You’re most likely to contract C. diff five to 10 days after starting antibiotics.
“One of the main complications of taking antibiotics is that they can lead to C. diff, a serious gastrointestinal infection that can cause not only diarrhea and be uncomfortable for the person who’s affected, but it can lead to major complications that require hospitalization, and in the worst cases even require surgery to remove part of the intestine,” Diemert said.
Recruiting people 65 and up
People over 65 are eligible for the study if they took an antibiotic within the past three months; or were hospitalized within the past year; or had frequent visits to the doctor within the past year. (The trial is only for people who have never been diagnosed with C. diff.)
Pfizer will compensate participants for their time.
Three in-person visits
The study requires at least three in-person visits to GW, located in Foggy Bottom in Washington, D.C. Diemert’s team will also keep in touch by phone at least three times. If patients happen to have gastrointestinal symptoms, Diemert’s team may ask them to come into the office again.
The first visit will last about two hours to fill out paperwork and receive an injection in their upper arm “just like a flu shot,” Diemert said. Six months later, they will get the second and final dose in a visit that will take less than an hour.
One group of people will receive two doses of the investigational vaccine (a traditional vaccine, not an mRNA or live vaccine). The other group will get two doses of a placebo, or saltwater shot.
On average, each person is expected to keep in touch with the research team for up to three and a half years.
If scientists can find a way to prevent C. diff, it would be a major medical breakthrough.
“It’s a really serious infection, and it’s a major problem, especially in hospitals, because C. diff can be transmitted between patients,” Diemert said.
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